Comparison of Nasal Steroids After FESS in CRSwNP

Status Completed

Clinical Trial Summary

The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal saline rinses in both the upright and head forward positions in patients who have had functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with nasal polyposis (CRSwNP) and measure differences in Sinonasal Outcome Test-22 (SNOT-22) scores and Lund- Kennedy scores on rigid nasal endoscopy at time points 1 week, 3 weeks, 6 weeks, 2 months, 4 months, and 6 months post-op.

Clinical Trial Description

Chronic rhinosinusitis (CRS) is an inflammatory condition of the lining of the nose and sinuses that lasts 12 weeks or longer with objective evidence of mucosal inflammation (1). CRSwNP is characterized by the presence of bilateral nasal polyps in the middle meatus. Patients with CRSwNP for whom medical therapy has failed, often have functional endoscopic sinus surgery.

Nasal steroids are important post-operatively to prevent polyps from recurring. Many studies have shown that nasal steroids are superior to placebo in maintaining improvement in symptom scores, such as SNOT-22, post-operatively by preventing polyps from returning (2). Nasal steroids can reduce inflammation locally and can prevent disease relapse without the systemic effects of oral steroids. However, there is no consensus as to which nasal steroid and which delivery method is most effective in treating these patients. Traditional nasal sprays, such as fluticasone spray, may not deliver the medication widely in the nasal cavity. Budesonide is available in a respule form that can be used to instill the medication in the nose. In an attempt to more effectively deliver the medication, changes in patient's head position has been prescribed to achieve better delivery (3). The safety of intranasal budesonide, a more potent steroid than fluticasone, has been established (4, 5). However, any improved efficacy over fluticasone nasal spray remains anecdotal as head to head comparisons have not previously been performed.

Practice patterns among rhinologists in the post-operative prescription of nasal steroids vary widely. Determining which medication/delivery method is more effective will help rhinologists better treat their patients and prevent symptoms, for which the surgery was performed, from returning. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02194062
Study type	Interventional
Source	Yale University
Contact
Status	Completed
Phase	N/A
Start date	January 2015
Completion date	August 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.